(1)

Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 contains the list of harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation.

(2)

Proposals to introduce harmonised classification and labelling of certain substances and to update or delete the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency (the ‘Agency’) pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk Assessment of the Agency (RAC) adopted, after having taken account of the comments received from the parties concerned, the following opinions (2) on those proposals:

(3)

Additional information was received contesting the scientific assessment set out in the RAC opinions of 11 June 2020 concerning 2-ethylhexanoic acid and its salts; of 11 June 2020 concerning a reassessment at the request of the European Commission of the developmental toxicity of N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) (DTPA) and its pentasodium and pentapotassium salts; of 8 October 2020 concerning ammonium bromide; of 10 December 2020 concerning divanadium pentaoxide; of 10 December 2020 concerning a reassessment at the request of the European Commission of the new information on acute inhalation toxicity of 2-butoxyethanol; ethylene glycol monobutyl ether (EGBE); and of 10 December 2020 concerning melamine.

(4)

This additional information was assessed by the Commission and was not found sufficient to cast doubts on the scientific analysis contained in the RAC opinions. It is therefore appropriate to introduce, update or delete the harmonised classification and labelling of the substances concerned on the basis of the assessment made in those opinions.

(5)

Additional information pertaining to the acute inhalation toxicity of silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide was received after the RAC opinion was forwarded to the Commission. The classification of silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide as acute toxic by inhalation Cat. 2, recommended in the RAC opinion of 5 December 2019, should not be included in Annex VI to Regulation (EC) No 1272/2008, as the new scientific information was assessed by the Commission and was found to require further assessment by RAC. However, the classification of this substance as STOT RE 2, recommended in the RAC opinion of 5 December 2019, should be included in Annex VI to Regulation (EC) No 1272/2008, since no new information has been received that would require further assessment for that classification.

(6)

Regulation (EC) No 1272/2008 should therefore be amended accordingly.

(7)

Compliance with the new or updated harmonised classifications should not be required immediately as a certain period of time is necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new or updated classifications and to sell existing stocks subject to the pre-existing regulatory requirements. That period of time is also necessary to allow suppliers sufficient time to take the actions required to ensure continuing compliance with other legal requirements following the changes made under this Regulation. Suppliers should, however, have the possibility to apply the new or updated harmonised classifications, and to adapt the labelling and packaging accordingly, on a voluntary basis before the date of application of this Regulation, to ensure a high level of protection of human health and of the environment and to provide sufficient flexibility to suppliers,

(1)

The Republic of Vanuatu is listed in Annex II to Regulation (EU) 2018/1806 among the third countries whose nationals are exempt from the requirement to be in possession of a visa when crossing the external borders of the Member States for stays of no more than 90 days in any 180-day period. The exemption from the visa requirement for nationals of Vanuatu is applicable since 28 May 2015, when the Agreement between the European Union and the Republic of Vanuatu on the short-stay visa waiver (2) (‘the Agreement’) was signed and started to apply on a provisional basis in accordance with Article 8(1) of the Agreement. The agreement entered into force on 1 April 2017.

(2)

On 3 March 2022, the Council adopted Decision (EU) 2022/366 (3) on the partial suspension of the application of the Agreement between the European Union and the Republic of Vanuatu on the short-stay visa waiver, in accordance with Article 8(4) of the Agreement. The suspension of the application of the Agreement is limited to ordinary passports issued as of 25 May 2015, when the number of successful applicants under Vanuatu’s investor citizenship schemes started to increase significantly.

(3)

Whilst Decision (EU) 2022/366 suspended the Agreement between the European Union and the Republic of Vanuatu on the short-stay visa waiver, it is also necessary to provide for the suspension at the level of Union law.

(4)

According to Article 8(3) and (6) of Regulation (EU) 2018/1806, where the Commission has concrete and reliable information that the circumstances referred to in Article 8(2), point (d) exist, namely ‘an increased risk or imminent threat to the public policy or internal security of Member States substantiated by objective, concrete and relevant information and data provided by the competent authorities’, the Commission is to adopt an implementing act temporarily and partially suspending the exemption from the visa requirement for a period of nine months.

(5)

By means of Vanuatu’s investor citizenship schemes operated by Vanuatu since 25 May 2015, third country nationals who are otherwise visa-required have the possibility to obtain the citizenship of Vanuatu in exchange for investment, therefore obtaining visa-free access to the Union.

(6)

The said schemes do not contain any requirement of effective residence or physical presence in Vanuatu for the applicants. The application process is managed by specialised agencies located outside Vanuatu (e.g., in Dubai, Thailand and Malaysia) whereby the applicant does not need to have any direct contact with Vanuatu’s authorities. The absence of a requirement for a physical interview reduces the opportunities for the authorities of Vanuatu to properly assess the applicant or to corroborate the information provided in the application, including its veracity and credibility. The schemes are commonly advertised as a way to by-pass the Schengen visa procedure and easily obtain visa-free access to the EU (4). The attractiveness of Vanuatu’s schemes is commercially based on their fast-track screening procedures and their light checks on the origin of the funds.

(7)

As confirmed by Vanuatu’s authorities, the applications are processed within very short deadlines (5). Such short processing periods do not allow for a proper security screening and exchange of information with the applicants’ country of origin or main past residence before the granting of the citizenship. Due to this short processing period and to the absence of systematic exchange of information with the applicants’ country of origin, Vanuatu had granted the citizenship to persons subject to a criminal investigation, including persons listed on Interpol’s databases.

(8)

The rejection rate is extremely low, thus corroborating the Commission’s assessment concerning the security failures and the low reliability of the screening process. According to information provided by Vanuatu’s Passport Office on 14 June 2021, until March 2021, Vanuatu issued over 10 500 passports in exchange for investment under the schemes and by the end of 2020 the Vanuatu authorities had rejected only one application.

(9)

Furthermore, the countries of origin of successful applicants include some that are typically excluded from other citizenship schemes, such as Iran and Afghanistan, and other countries whose nationals need a visa for short stays in the EU, including Nigeria, Yemen, Syria, Pakistan and Libya.

(10)

The security risks are further exacerbated by the lax legislation on name changes. As confirmed by Vanuatu’s authorities during the technical meeting held on 15 April 2021, successful citizenship-by-investment applicants can also apply for an identity change.

(11)

The aforementioned circumstances lead to the conclusion that the citizenship-by-investment schemes of Vanuatu, in their current form and operation, go against the objectives of the Union’s visa policy, which provides for a screening of nationals from visa-required third countries against the criteria set out in Article 21 of Regulation (EC) No 810/2009 (6) and in equivalent national legislation of those Member States where Regulation (EC) No 810/2009 does not yet apply in full. The relevant case by case verifications are carried out in the light of criteria relating, inter alia, to public policy and security. The manner in which the said schemes are being implemented constitutes a circumvention of the Union short-stay visa procedure and the assessment of security and migratory risks it entails.

(12)

In exchanges between the Commission and Vanuatu’s authorities in October 2017, November 2019, June 2020 and March 2021, the Commission expressed serious concerns regarding the granting of citizenship to persons listed in Interpol databases, the absence of physical presence or residence requirements, the schemes’ short processing periods and the lack of systematic exchange of information with applicants’ countries of origin or past main residence, and warned the government of Vanuatu of the possibility of the visa requirement being reinstated. The explanations provided by Vanuatu were not sufficient to alleviate those concerns.

(13)

Taking account of the aforementioned information and data, reports and statistics, and in accordance with Article 8(2)(d), 8(3) and 8(6) of Regulation (EU) 2018/1806, the Commission concludes that the granting of citizenship by Vanuatu under its investor citizenship schemes constitutes an increased risk to the internal security and public policy of the Member States and has decided that action is needed.

(14)

The increased risk to the public policy and internal security linked to the nationals of Vanuatu having obtained the citizenship under the investor citizenship schemes can be mitigated only by means of a partial suspension of the visa exemption.

(15)

In accordance with Article 8(6) of Regulation (EU) 2018/1806, the Commission should, based on the information available, include categories that are broad enough in order to efficiently contribute to remedying the circumstances while respecting the principle of proportionality. Therefore, since Vanuatu does not differentiate between passports issued under investor citizenship schemes and other passports, the suspension should apply to all ordinary passports issued as of 25 May 2015, date on which Vanuatu started issuing a substantial number of passports in exchange for investment.

(16)

Nationals of Vanuatu who entered the EU before the date of entry into force of this Regulation should be allowed to continue their stay in the EU and exit without a visa. This should not apply for the crossing of temporary external borders between Member States as defined in Article 2, point c of Regulation (EU) No 515/2014 of the European Parliament and of the Council (7).

(17)

As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters’ association with the implementation, application and development of the Schengen acquis, which fall within the area referred to in point B of Article 1 of Council Decision 1999/437/EC (8).

(18)

As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement signed between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis, which fall within the area referred to in points B and C of Article 1 of Decision 1999/437/EC, read in conjunction with Article 3 of Council Decision 2008/146/EC (9).

(19)

As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis, which fall within the area referred to in points B and C of Article 1 of Decision 1999/437/EC, read in conjunction with Article 3 of Council Decision 2011/350/EU (10).

(20)

This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (11); Ireland is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application.

(21)

This Regulation constitutes an act building upon, or otherwise relating to, the Schengen acquis within, respectively, the meaning of Article 3(1) of the 2003 Act of Accession, Article 4(1) of the 2005 Act of Accession and Article 4(1) of the 2011 Act of Accession.

(22)

The measures provided for in this Regulation are in accordance with the opinion of the committee established in accordance with Article 11(1) of Regulation (EU) 2018/1806,

(1)

Regulation (EC) No 1071/2009 has been amended by Regulation (EU) 2020/1055 of the European Parliament and of the Council (2) which added new serious infringements with regard to the law applicable to contractual obligations, cabotage and posting of workers in road transport to the list of infringements that may lead to the loss of good repute set out in Article 3(1), point (b), of Regulation (EC) No 1071/2009.

(2)

Regulation (EU) 2020/1055 also introduced an additional criterion to be taken into account by the Commission when defining the degree of seriousness of serious infringements, by adding the reference to the risk to distort competition in the road transport market.

(3)

Regulation (EU) 2020/1055 also amended Regulation (EC) No 1071/2009 in order to provide that, when establishing the frequency of occurrence beyond which repeated infringements are to be regarded as more serious, the Commission should take into account the number of vehicles, and not the number of drivers, used for the transport activities.

(4)

Regulation (EU) 2020/1054 of the European Parliament and of the Council (3) introduced new provisions as regards infringements leading to risks of serious injuries or fatalities or distortion of competition in the road transport market. Those infringements should be added to the list of serious infringements of the Union rules referred to in Article 6(1), third subparagraph, point (b), of Regulation (EC) No 1071/2009, which may affect good repute of the road transport undertaking or the transport manager.

(5)

Therefore, Commission Regulation (EU) 2016/403 (4) should be amended to include the new infringements and take into account the new criteria for defining their level of seriousness and frequency of occurrence.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on Road Transport,

(1)

Effective and cost-efficient enforcement of the Union road transport legislation is of paramount importance for improving road safety, drivers’ working conditions and social protection and ensuring fair competition between road transport undertakings.

(2)

National risk rating systems introduced by Member States to better target controls at undertakings with high-risk rating are based on different national calculation methods. This hampers comparability and exchange of information on risk scores in the context of cross-border enforcement.

(3)

Article 9(1), second subparagraph of Directive 2006/22/EC requires the Commission to establish, by means of implementing acts, a common formula for calculating the risk rating of an undertaking.

(4)

In establishing this formula, the Commission should take into account all infringements susceptible to affect the risk rating of the undertakings, which includes infringements of Regulation (EC) No 561/2006 of the European Parliament and of the Council (2), of Regulation (EU) No 165/2014 of the European Parliament and of the Council (3), of national provisions transposing Directive 2002/15/EC of the European Parliament and of the Council (4), and the infringements specified in Article 6 of Regulation (EC) No 1071/2009 of the European Parliament and of the Council (5).

(5)

The common formula should take into account the number, gravity and frequency of occurrence of infringements, the results of controls where no infringement has been detected and whether a road transport undertaking has been using the smart tachograph, pursuant to Chapter II of Regulation (EU) No 165/2014, on all its vehicles.

(6)

The common formula for calculating the risk rating of an undertaking should contribute significantly to the harmonisation of enforcement practices throughout the Union, by ensuring that all drivers and transport undertakings are treated equally as regards checks and sanctions under the applicable Union rules.

(7)

Where the measures provided for in this Regulation entail the processing of personal data, they should be carried out in accordance with Union law on the protection of personal data and privacy, in particular Regulation (EU) 2016/679 of the European Parliament and of the Council (6), and, where applicable, Directive 2002/58/EC of the European Parliament and of the Council (7).

(8)

The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 42(1) of Regulation (EU) No 165/2014,

(1)

Directive 91/676/EEC lays down rules on the protection of waters against pollution caused by nitrates from agricultural sources.

(2)

Paragraph 2 of Annex III to Directive 91/676/EEC establishes that Member States intending to apply more livestock manure than 170 kg nitrogen per hectare (ha) are to fix amounts so as not to prejudice the achievement of the objectives specified in Article 1 of that Directive. These amounts are to be justified on the basis of objective criteria.

(3)

On 22 October 2007, the Commission adopted Decision 2007/697/EC (2) granting a derogation requested by Ireland pursuant to Directive 91/676/EEC for the purpose of allowing the application of livestock manure up to a limit of 250 kg nitrogen/ha per year, under certain conditions, on farms with at least 80 % grassland, in the context of the Irish Action Programme, as implemented by Ireland by means of the European Communities (Good Agricultural Practices for Protection of waters) Regulations 2006 (3).

(4)

On 24 February 2011, the Commission adopted Decision 2011/127/EU (4) amending Decision 2007/697/EC and extending the derogation until 31 December 2013, in the context of the Irish Action Programme as implemented by Ireland by means of the European Communities (Good Agricultural Practices for Protection of waters) Regulations 2010 (5).

(5)

On 27 February 2014, the Commission adopted Implementing Decision 2014/112/EU (6) granting a derogation requested by Ireland pursuant to Directive 91/676/EEC for the purpose of allowing the application of livestock manure up to a limit of 250 kg nitrogen/ha per year, under certain conditions, on farms with at least 80 % grassland, in the context of the Irish Action Programme as implemented by Ireland by means of the European Communities (Good Agricultural Practices for Protection of waters) Regulations 2014 (7).

(6)

On 8 February 2018, the Commission adopted Implementing Decision (EU) 2018/209 (8) granting a derogation requested by Ireland pursuant to Directive 91/676/EEC for the purpose of allowing the application of livestock manure up to a limit of 250 kg nitrogen/ha per year, under certain conditions, on farms with at least 80 % grassland, in the context of the Irish Action Programme as implemented by Ireland by means of the European Union (Good Agricultural Practices for Protection of waters) Regulations 2017 (9). Implementing Decision (EU) 2018/209 expired on 31 December 2021.

(7)

The derogation granted by Implementing Decision (EU) 2018/209 concerned, in 2020, 6 016 farms, corresponding to approximately 4,9 % of the total number of holdings with grazing animals, 15,9 % of the total number of livestock units and 9,6 % of the total net agricultural area in Ireland.

(8)

On 14 October 2021, Ireland submitted to the Commission a request for an extension of the derogation under paragraph (2), third subparagraph, of Annex III to Directive 91/676/EEC.

(9)

In accordance with the European Union (Good Agricultural Practice for Protection of Waters) Regulations 2022 (10), Ireland has adopted a new action programme with additional and reinforced measures to comply with the objectives of Directive 91/676/EEC.

(10)

In conformity with Article 5(2) of Directive 91/676/EEC, Ireland applies an action programme throughout its whole territory.

(11)

The data provided by Ireland in the context of the reporting obligation required by Article 10 of Directive 91/676/EEC show that, for the period 2016-2019, the waters are of generally good quality. In this regard, 98,5 % of all monitoring stations for groundwater in Ireland had mean nitrate concentrations below 50 mg/l, and 81,5 % of those monitoring stations had mean nitrate concentrations below 25 mg/l. All monitoring stations for surface water in Ireland had mean nitrate concentrations below 50 mg/l, and 99,2 % of those monitoring stations had mean nitrate concentrations below 25 mg/l. Furthermore 14 % of the surface water monitoring stations reported eutrophication and 10 % reported risk of eutrophication. Regarding trends, 37,5 % of groundwater monitoring stations reported an increase of nitrate concentrations, 45,5 % reported stable trends and 17 % reported decreasing trends. As regards surface water, 11,1 % of monitoring stations reported an increase of nitrate concentrations, 86,2 % reported stable trends and 2,8 % reported decreasing trends.

(12)

The number of livestock in Ireland has increased in recent years. Cattle, pig and sheep numbers increased respectively by 4,78 %, 2,81 % and 0,54 % from the period 2012-2015 to the period 2016-2019, pursuing the increasing trends of the previous reporting period. Average nitrogen loading from livestock manure in the period 2016-2018 was 117 kg nitrogen/ha, compared to 104 kg nitrogen/ha in the period 2012-2015. Average phosphorus loading in the period 2016-2018 was 14 kg phosphorus/ha compared to 15 kg phosphorus/ha in the period 2012-2015. Average chemical nitrogen fertiliser application increased by 13 % in the period 2016-2019 compared to the period 2012-2015. Average chemical phosphorus fertiliser application increased by 24 % in the period 2016-2019 compared to the period 2012-2015. Average phosphorus surplus in the period 2016-2018 was 23,1 kg phosphorus/ha compared to 20 kg phosphorus/ha in the period 2012-2015. Average nitrogen surplus in the period 2016-2018 was 62,3 kg nitrogen/ha compared to 44,8 kg nitrogen/ha in the period 2012-2015.

(13)

In Ireland, 92 % of agricultural land is devoted to grassland. Overall, 67 % of the land area is farmed extensively and has therefore a relatively low stocking rate and low fertiliser inputs, 33 % is farmed under agro-environmental programmes and only 14 % is farmed intensively. Arable agriculture accounts for 6,6 % of use. The average chemical fertiliser use on grassland is 78,3 kg nitrogen/ha and 8,6 kg phosphorus/ha.

(14)

The Irish climate, characterised by an annual rainfall evenly distributed throughout the year and a relatively narrow annual temperature range, promotes a long grass-growing season ranging from 330 days per year in the south-west to around 250 days per year in the north-east (11).

(15)

The supporting information presented by Ireland shows that the proposed amount of 250 kg nitrogen/ha per year on farms with at least 80 % grassland is justified on the basis of objective criteria, such as long growing seasons and high yields of grass with high nitrogen uptake.

(16)

After an examination of the request from Ireland in accordance with paragraph 2, third subparagraph, of Annex III to Directive 91/676/EEC, and in the light of the Irish Action Programme coupled with the experience gained from the derogation provided for in Decision 2007/697/EC and Implementing Decisions 2014/112/EU and (EU) 2018/209, the Commission considers that the amount of manure proposed by Ireland, corresponding to 250 kg nitrogen/ha per year, will not prejudice the achievement of the objectives set out in Directive 91/676/EEC, subject to certain strict conditions that should apply to farmers covered by authorisation.

(17)

In the light of the data referred to in recitals 11 to 13, the conditions provided for in this Decision should be strengthened compared to those provided for in Implementing Decision (EU) 2018/209. The conditions established as well as the monitoring and control systems should be sufficient to ensure that this derogation is coherent with the legally binding targets of the Water Framework Directive (12), the increasing ambition of Effort Sharing Regulation (13) as well as the aspirational objectives of the European Green Deal concerning nutrient pollution.

(18)

Additional measures should be taken as regards the application of manure and other fertilisers. These measures should contribute to the improvement in nutrient management through optimised fertilisation and limited use of fertilisers. The measures listed in this Decision should be additional to the measures already being applied through the Code of Good Agricultural Practices.

(19)

Yearly administrative controls and field inspections should be increased to 10 % of farms benefiting from an authorisation. Field inspections should be based on a sound methodology, including risk assessment, random controls and the results of controls of the previous years. The national authorities should review the agricultural inspection programme carried out by the local authorities as well as the resources required to perform the inspections. Dissuasive sanctions (including economic) should be applied. Complaints or reports of non-compliance from citizens, non-governmental organisations or whistle-blowers should be followed up.

(20)

In 2023, the Irish authorities should carry out a two-year review of water quality, including nitrate concentration and trophic status. In areas where monitoring data reveal either worsening trends or a situation of pollution or risk of pollution as regards nitrate concentrations or eutrophication, from 2024, the maximum amount of manure applicable that may be applied should be reduced to 220 kg nitrogen/ha.

(21)

The monitoring requirements of nitrate concentration and trophic status in accordance with Directive 91/676/EEC continue to apply. The two-year review should be based on data from this monitoring. Additional monitoring and yearly reporting in the areas covered by the derogation will be necessary.

(22)

Directive 2007/2/EC of the European Parliament and of the Council (14) lays down general rules for establishing the Infrastructure for Spatial Information in the Union for the purposes of environmental policies of the Union and policies or activities which may have an impact on the environment. Where applicable, the spatial information collected pursuant to this Decision should be in line with the provisions set out in that Directive. In order to reduce the administrative burden and enhance data coherence, Ireland, when collecting the necessary data under this Decision, should make use of the information generated under the Integrated Administration and Control System established pursuant to Title V, Chapter II, of Regulation (EU) No 1306/2013 of the European Parliament and of the Council (15).

(23)

The derogation provided for in this Decision is without prejudice to the obligations of Ireland to apply Council Directive 92/43/EEC (16), including the ruling of the Court of Justice of the European Union in Case C-293/17 Coöperatie Mobilisation for the Environment and Vereniging Leefmilieu (17), in particular on the interpretation of Article 6(3) of that Directive.

(24)

The conditions laid down in Articles 6 to 9 of this Decision are mandatory conditions for all grassland farms benefitting from an authorisation under the derogation. These conditions are therefore considered as mandatory standards and requirements established in national law for these entities in the meaning of Article 12 and 13 of Regulation (EU) 2021/2115 of the European Parliament and of the Council (18).

(25)

The measures provided for in this Decision are in accordance with the opinion of the Nitrates Committee set up pursuant to Article 9 of Directive 91/676/EEC,